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Gurugram, Haryana, India
Hybrid
What you will do:
Support new product and process introductions in accordance with Stryker’s Product Development Process (PDP) and quality system requirements.
Support Computer System Validation (CSV) activities for manufacturing systems, software applications, automation solutions, and digital tools in accordance with regulatory requirements and company procedures. Develop and execute validation documentation, including validation plans, risk assessments, test protocols, and reports.
Design, execute, and document process qualifications, equipment qualifications, and validation activities (IQ/OQ/PQ).
Review, approve, and maintain validation and technical documentation.
Collaborate with Quality Engineering to establish inspection methods, test protocols, and acceptance criteria for components and finished products.
Support risk management activities, including PFMEA development, Control Plans, SOPs, and PPAP documentation.
Conduct Measurement System Analysis (MSA) and capability studies for new products and manufacturing processes.
Ensure compliance with applicable regulatory, GMP, safety, and environmental requirements.
What you will need:
Required Qualifications:
Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or a related technical discipline.
Minimum 2 years of engineering experience in medical device, regulated manufacturing, or a similar high-technology environment.
Strong understanding of manufacturing processes, equipment qualification, and process validation methodologies.
Knowledge of quality and regulatory requirements, including GMP, FDA, ISO 13485, and risk management principles.
Ability to interpret engineering drawings, specifications, and Geometric Dimensioning & Tolerancing (GD&T).
Experience with statistical tools, process capability analysis, and root-cause problem-solving methodologies.
Preferred Qualifications:
Strong project management, organizational, and multitasking skills.
Excellent communication and interpersonal skills with the ability to collaborate effectively across multidisciplinary teams.
Self-motivated, results-oriented professional with a continuous improvement mindset.